Cstone — Cejemly EMA EPAR public assessment report (EMEA/H/C/006088, 2024)
Cstone · 2024 · EMA EPAR public assessment report
Report summary
The European Medicines Agency has granted marketing authorization for Cejemly (sugemalimab) for the first-line treatment of metastatic non-small cell lung cancer (NSCLC) without specific EGFR, ALK, ROS1, or RET genomic aberrations. The application, submitted by SFL Pharmaceuticals Deutschland GmbH, received a positive opinion from the CHMP. Manufacturing processes, quality control, and stability of sugemalimab were deemed satisfactory. The pivotal CS1001-302 (GEMSTONE-302) Phase III study demonstrated statistically significant improvements in progression-free survival (PFS) and overall survival (OS) for sugemalimab plus chemotherapy compared to placebo plus chemotherapy. Safety data, primarily from studies in China, showed common treatment-emergent adverse events, and the benefit-risk assessment was positive, supporting the marketing authorization.
Key findings — cited to the page
| Any TEAE of Grade 3-5 in sugemalimab + chemotherapy (101b NSCLC) arm | 85.4 % | CS1001-101b · p.100 |
| Any TEAE of Grade 3-5 in sugemalimab + chemotherapy (Total) arm | 69.4 % | · p.100 |
| Any TEAE of Grade >= 3 in placebo + chemotherapy arm | 62.3 % | CS1001-302 · p.98 |
| Any TEAE of Grade 3-5 in sugemalimab + chemotherapy (302 NSCLC) arm | 64.7 % | CS1001-302 · p.100 |
| Any TEAE of Grade 3-5 in sugemalimab + chemotherapy (Total NSCLC) arm | 67.0 % | · p.100 |
| Any TEAE of Grade 3-5 in sugemalimab + chemotherapy (Other Indications) arm | 81.1 % | · p.100 |
| Grade 3-5 TEAEs (Control) | 62.3 % | · p.128 |
| Any TEAE of Grade >= 3 in sugemalimab + chemotherapy arm | 64.7 % | CS1001-302 · p.98 |
| Any treatment-related TEAE of Grade >= 3 in sugemalimab + chemotherapy arm | 57.8 % | CS1001-302 · p.98 |
| Any treatment-related TEAE of Grade >= 3 in placebo + chemotherapy arm | 57.9 % | CS1001-302 · p.98 |
| Grade 3-5 TEAEs | 64.7 % | · p.128 |
| Any TEAE of Grade 3-5 in sugemalimab monotherapy arm | 31.9 % | · p.100 |
Source: Cstone ↗ · License: EMA - reuse permitted with acknowledgement. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Oncology library →